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Author = McCaffery, Fergal;
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Displaying Results 1 - 25 of 155 on page 1 of 7
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A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps
(2014)
Flood, Derek; McCaffery, Fergal; Regan, Gilbert; Casey, Valentine
A Critical Evaluation of a Methodology for the Generation of Software Process Improvement Roadmaps
(2014)
Flood, Derek; McCaffery, Fergal; Regan, Gilbert; Casey, Valentine
Abstract:
For medical device organisations to market their devices in specific geographic regions they must adhere to the regulations of that region. These regulations often recommend that organisations adhere to specific standards and guidance documents which specify “what” must be achieved without specifying “how” this may be done. Due to changes to the medical device directive, which governs the development of medical devices within the EU, in March 2010, software can now in its own right be considered a medical device. This change has meant that a number of software organisations developing software for the medical device domain must now adhere to the same regulations as other medical device manufacturers. In this work we present a concept for a Software Process Improvement (SPI) roadmap to guide such organisations through the task of implementing medical device standards and guidance documents. In addition we present and evaluate a methodology that can be used to create a SPI roadmap fro...
http://eprints.dkit.ie/408/
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A Hybrid Assessment Approach for Medical Device Software Development Companies
(2018)
McCaffery, Fergal; Ozcantop, Ozden
A Hybrid Assessment Approach for Medical Device Software Development Companies
(2018)
McCaffery, Fergal; Ozcantop, Ozden
Abstract:
Medical device software development organizations are bound by regulatory requirements and constraints to ensure that developed medical devices will not harm patients. Medical devices have to be treated as complete systems and be evaluated in this manner. Instead of manufacturers having to ensure compliance to various regulatory standards individually, the authors previously developed a medical device software process assessment framework called MDevSPICE® that integrates the regulatory requirements from all the relevant medical device software standards. The MDevSPICE® was developed in a manner that suits plan‐driven software development. To improve the usability of MDevSPICE® in agile settings, we extended the assessment approach. The hybrid assessment approach described here combines the MDevSPICE®‐based process assessment method with steps for prioritization of improvement needs through value stream mapping and enabling process improvement through the use of KATA technique. This...
http://eprints.dkit.ie/596/
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A lightweight assessment method for medical device software processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
A lightweight assessment method for medical device software processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
Abstract:
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment an...
http://doras.dcu.ie/21090/
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A Lightweight Assessment Method for Medical Device Software Processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
A Lightweight Assessment Method for Medical Device Software Processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
Abstract:
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE® software process assessment model which is currently being developed for the medical device industry. MDevSPICE® is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE® process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing a MDevSPICE-Adept process assessment are presented. Information is also provided regarding how a MDevSPICE® process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment ...
http://eprints.dkit.ie/403/
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A Lightweight Software Process Assessment Approach based on MDevSPICE® for Medical Device Development Domain
(2017)
McCaffery, Fergal; Özcan-Top, Ozden
A Lightweight Software Process Assessment Approach based on MDevSPICE® for Medical Device Development Domain
(2017)
McCaffery, Fergal; Özcan-Top, Ozden
Abstract:
Software process improvement is challenging in the medical device development domain, as significant constraints exist such as ensuring conformance to regulations while improving software quality. The regulations that medical products are subject to may be overwhelming for organisations as a variety of international standards have to be implemented in order to address regulatory compliance. MDevSPICE® is a framework developed to overcome this challenge by integrating different international regulatory standards’ requirements with generic software development best practices. Keeping the complexity of the domain in mind, the formal process assessments performed based on MDevSPICE® are highly detailed and require significant resource and effort investment. With the MDevSPICE® lightweight software process assessment approach, we aim to obtain maximum benefit from an assessment within a limited time by assessing all processes within MDevSPICE®, specifying and presenting major issues in p...
http://eprints.dkit.ie/594/
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A Low-Overhead Method for Software Process Appraisal
(2007)
Wilkie, F.G; McCaffery, Fergal; McFall, D; Lester, Neil; Wilkinson, E
A Low-Overhead Method for Software Process Appraisal
(2007)
Wilkie, F.G; McCaffery, Fergal; McFall, D; Lester, Neil; Wilkinson, E
Abstract:
This paper describes a low-overhead method of software process appraisal that has been developed and used by the Centre for Software Process Technologies (CSPT) to appraise small-to-medium-sized software development organisations in Northern Ireland (NI) that have little or no experience of software process improvement programmes. During the appraisal, information is collected and reviewed to produce a findings report. The findings report consists of a list of strengths, issues and suggested actions for each of the process areas evaluated. The suggested actions detail how the assessed company may improve their processes in line with their business goals. Because the NI software industry is mainly composed of small-to-medium sized software development companies, it is sometimes difficult, both in terms of financial expense and time, for such companies to engage in regular appraisals with the CSPT appraisal team. Therefore, since the main purpose of the CSPT is to instil a software p...
http://eprints.dkit.ie/220/
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A Methodology for Software Process Improvement Roadmaps for Regulated Domains – Example with ISO 62366
(2013)
Flood, Derek; McCaffery, Fergal; Casey, Valentine; Regan, Gilbert
A Methodology for Software Process Improvement Roadmaps for Regulated Domains – Example with ISO 62366
(2013)
Flood, Derek; McCaffery, Fergal; Casey, Valentine; Regan, Gilbert
Abstract:
Software process improvement initiatives offer many benefits in terms of productivity, cost savings and quality. As part of these initiatives organisations undergo an assessment and then embark on a software process improvement program to improve their existing processes to meet a desired target. These programs can be improved by the use of process improvement roadmaps that are tailored to the organisation and are usually non-transferrable. Within regulated domains, such as the medical device industry, adherence to international standards must be achieved before products can be placed on the market. This work proposes the use of software process improvement roadmaps to assist organisations achieve compliance with medical device standards. These proposed roadmaps will be generic in nature to meet the requirements of the standard, but will be subsequently tailored to meet the specific requirements of an individual organisation. In this paper we introduce the concept of the software pr...
http://eprints.dkit.ie/608/
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A Proposed Way for European Software Industries to Achieve Growth Within the Global Marketplace
(2006)
McCaffery, Fergal; Smite, Darja; Wilkie, F.G; McFall, D
A Proposed Way for European Software Industries to Achieve Growth Within the Global Marketplace
(2006)
McCaffery, Fergal; Smite, Darja; Wilkie, F.G; McFall, D
Abstract:
Global market expansion forces the competition in the field of software development to grow extremely fast. Accordingly, countries that base their brand in the field of information technologies are looking forward to quality and productivity improvement along with price reduction. One of the major trends in the global market is outsourcing, which is considered to be an opportunity to achieve best knowledge, extra resources and assurance of quality development, speed time to market, and cut costs. The role of emerging nations in this context increases every day, pushing out the old players. This article will therefore suggest how software development should change within the Northern Ireland (NI) software industry and adopt a global software development model in order to continue as a major player within the global software development industry.
http://eprints.dkit.ie/206/
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A Risk Management Capability Model for use in Medical Device Companies
(2006)
Burton, John; McCaffery, Fergal; Richardson, Ita
A Risk Management Capability Model for use in Medical Device Companies
(2006)
Burton, John; McCaffery, Fergal; Richardson, Ita
Abstract:
Medical device software is a risky business. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. It is therefore no surprise that regulators throughout the world are penalising medical device manufacturers that do not demonstrate that sufficient attention is devoted to the areas of hazard analysis and risk management (RM) throughout the software lifecycle. If a medical device company fails to comply with the regulations of a given country, in effect they surrender their legal right to market their device in that country. With so much at stake, it is in everybody’s best interest that the medical device manufacturer gets it right. However, with so many different standards, regulatory guidance papers and industry guides on RM, the task of collating this information into a usable model is itself daunting. This paper seeks to extract the important concepts from a number of industry accepted standards and guides, and prese...
http://eprints.dkit.ie/134/
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A roadmap to ISO 14971 implementation
(2015)
Rust, Peter; McCaffery, Fergal; Casey, Valentine; McKeever, Ruth; Flood, Derek
A roadmap to ISO 14971 implementation
(2015)
Rust, Peter; McCaffery, Fergal; Casey, Valentine; McKeever, Ruth; Flood, Derek
Abstract:
Medical device standards outline the requirements for developing medical devices. These standards, however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain. The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard. The validation examined the arrangement of the milestones within the roadmap and grouping of the goals into milestones. Five experienced risk management personnel in the medical device domain were asked to complete an online questionnaire examining their opinion on the structure and content of the roadmap. Overall participants found the roadmap, in general, to be well structured and well organised and made some recommendations for improving the roadmap through merging of specific goals and rearrangement of the milestones within the roadmap.
http://eprints.dkit.ie/547/
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A Security Argument Pattern for Medical Device Assurance Cases
(2014)
Finnegan, Anita; McCaffery, Fergal
A Security Argument Pattern for Medical Device Assurance Cases
(2014)
Finnegan, Anita; McCaffery, Fergal
Abstract:
Medical device security is a growing concern for medical device manufacturers, healthcare delivery organisations and regulators in the industry. Increasingly, researchers are demonstrating exactly how vulnerable these devices are. In many cases, networked medical devices are regarded as a potential weak link within a healthcare IT network that could provide a means to expose the entire network to a malware attack. At present there is no formal method for implementing security risk management practices in the medical device industry. However, with new regulatory guidance being developed by the Food and Drug Administration (FDA), medical devices manufacturers will need to prove that their devices are secure. This paper presents a security case framework that is currently under development. The purpose of this framework is to provide medical device manufacturers and healthcare delivery organisations with a solution to assist both in establishing confidence in the security assurance of ...
http://eprints.dkit.ie/412/
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A Serverless Architecture for Wireless Body Area Network Applications
(2019)
Paul, Pangkaj Chandra; Loane, John; McCaffery, Fergal; Regan, Gilbert
A Serverless Architecture for Wireless Body Area Network Applications
(2019)
Paul, Pangkaj Chandra; Loane, John; McCaffery, Fergal; Regan, Gilbert
Abstract:
Wireless body area networks (WBANs) have become popular for providing real-time healthcare monitoring services. WBANs are an important subset of Cyber-physical systems (CPS). As the amount of sensing devices in such healthcare applications is growing rapidly, security, scalability, availability and privacy are a real challenge. Adoption of cloud computing is growing in the healthcare sector because it can provide high scalability while ensuring availability and affordable healthcare monitoring services. Serverless computing brings a new era to the design and deployment of event-driven applications in cloud computing. Serverless computing also helps the developer to build a large application using Function as a Service without thinking about the management and scalability of the infrastructure. The goal of this paper is to propose a dependable serverless architecture for WBAN applications. This architecture will improve the dependability of WBAN applications through ensuring scalabil...
http://eprints.dkit.ie/663/
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A Software Process Development, Assessment and Improvement Framework,for the Medical Device Industry
(2004)
McCaffery, Fergal; Donnelly, Peter; Dorling, Alec; Wilkie, F.G
A Software Process Development, Assessment and Improvement Framework,for the Medical Device Industry
(2004)
McCaffery, Fergal; Donnelly, Peter; Dorling, Alec; Wilkie, F.G
Abstract:
This paper describes a software process development, assessment and improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.
http://eprints.dkit.ie/144/
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A Software Process Improvement Initiative in Northern Ireland
(2004)
McFall, D; McCaffery, Fergal; Wilkie, F.G; Lester, Neil
A Software Process Improvement Initiative in Northern Ireland
(2004)
McFall, D; McCaffery, Fergal; Wilkie, F.G; Lester, Neil
http://eprints.dkit.ie/141/
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A Software Process Improvement Lifecycle Framework for the Medical Device Industry
(2005)
McCaffery, Fergal; McFall, D; Donnelly, Peter; Wilkie, F.G; Sterrit, Roy
A Software Process Improvement Lifecycle Framework for the Medical Device Industry
(2005)
McCaffery, Fergal; McFall, D; Donnelly, Peter; Wilkie, F.G; Sterrit, Roy
Abstract:
This paper describes a software process improvement framework to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [1] (US requirement), and the European Commission under its Medical Device Directives (MDD) [2] (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.
http://eprints.dkit.ie/137/
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A Software Process Improvement Roadmap for IEC 62304: an Expert Review
(2018)
Rust, Peter; Flood, Derek; Regan, Gilbert; McCaffery, Fergal
A Software Process Improvement Roadmap for IEC 62304: an Expert Review
(2018)
Rust, Peter; Flood, Derek; Regan, Gilbert; McCaffery, Fergal
Abstract:
Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in the European Union (EU). The EU has introduced this legislation and regulation to provide the frameworks by which manufacturers can produce safe and effective medical devices in a consistent manner. The EU has accomplished this by way of Medical Device Directives and harmonised standards. Manufactures, by demonstrating compliance with a harmonised standard, can be presumed to have complied with the essential requirements of the legislation. IEC 62304 Medical device software – Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard. A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard. The Roadmap is divided into two levels, the high l...
http://eprints.dkit.ie/626/
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A Traceability Process Assessment Model for the Medical Device Domain
(2014)
Regan, Gilbert; Biro, Miklos; McCaffery, Fergal; McDaid, Kevin; Flood, Derek
A Traceability Process Assessment Model for the Medical Device Domain
(2014)
Regan, Gilbert; Biro, Miklos; McCaffery, Fergal; McDaid, Kevin; Flood, Derek
Abstract:
Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as impact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software. Within the medical device domain, as in other safety critical domains, software must provide reliability, safety and security because failure to do so can lead to injury or death. However, despite its criticality most software systems don’t employ explicit traceability between artefacts. Numerous barriers hamper the effective implementation of traceability such as cost, complexity of relationship between artefacts, calculating a return on investment, different stakeholder viewpoints, lack of awareness of traceability and a lack of guidance as to how...
http://eprints.dkit.ie/407/
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Acceptance Test-Driven Development by annotation of existing documentation
(2010)
Connolly, David; Keenan, Frank; McCaffery, Fergal
Acceptance Test-Driven Development by annotation of existing documentation
(2010)
Connolly, David; Keenan, Frank; McCaffery, Fergal
Abstract:
Testing is frequently reported as a crucial stage in the software development process. With traditional approaches acceptance testing is the last stage of the process before release. Acceptance Test Driven Development (ATDD) promotes the role of an expert customer in defining tests and uses tool support to automate and execute these tests. This paper outlines a tool, AnnoTestWeb/Run aimed at expert customers specifying acceptance tests through reuse of existing documentation. Also outlined is a planned evaluation that includes industrial collaboration aimed at considering the impact of this tool on reuse of existing documentation
http://eprints.dkit.ie/169/
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Adept – A Software Process Appraisal Method for Small to Medium-sized Software Development Organisations
(2006)
McCaffery, Fergal; Richardson, Ita; Coleman, Gerry
Adept – A Software Process Appraisal Method for Small to Medium-sized Software Development Organisations
(2006)
McCaffery, Fergal; Richardson, Ita; Coleman, Gerry
Abstract:
In this paper we describe the appraisal method that was developed by Lero (the Irish Software Engineering Research Centre) and Dundalk Institute of Technology (DkIT) to assess software processes within small to medium-sized Irish software organisations that have little or no experience of software process improvement (SPI) programmes. We developed a method, called Adept, through investigating the key factors that contribute to an effective software assessment method, reflecting the desires of Irish SMEs in terms of providing a “manageable” approach to SPI and through expanding upon the Express Process Appraisal (EPA) method [1] to fulfil these objectives.
http://eprints.dkit.ie/173/
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Adept: A Unified Assessment Method for Small Software Companies
(2007)
McCaffery, Fergal; Taylor, Philip S.; Coleman, Gerry
Adept: A Unified Assessment Method for Small Software Companies
(2007)
McCaffery, Fergal; Taylor, Philip S.; Coleman, Gerry
http://eprints.dkit.ie/217/
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Adopting Agile Practices when Developing Medical Device Software
(2015)
McHugh, Martin; McCaffery, Fergal; Coady, Garret
Adopting Agile Practices when Developing Medical Device Software
(2015)
McHugh, Martin; McCaffery, Fergal; Coady, Garret
Abstract:
Agile methods are gaining momentum amongst the developers of non-safety critical software. They offer the ability to improve development time, increase quality and reduce development costs. Despite this, the rate of adoption of agile methods within safety critical domains remains low. On face value agile methods appear to be contradictory to regulatory requirements. However while they may appear contradictory, they align on key values such as the development of the highest quality software. To demonstrate that agile methods could in fact be adopted when developing regulatory compliant software they were implemented on a medical device software development project. This implementation showed that not only can agile methods be successfully followed, but it also revealed that benefits were acquired. For example, the medical device software development project was completed 7% faster when following agile methods, when compared to if it had been completed in accordance with a plan-driven...
https://arrow.dit.ie/ittsciart/34
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Adopting Agile Practices When Developing Software for Use in the Medical Domain
(2014)
McHugh, Martin; McCaffery, Fergal; Casey, Valentine
Adopting Agile Practices When Developing Software for Use in the Medical Domain
(2014)
McHugh, Martin; McCaffery, Fergal; Casey, Valentine
Abstract:
Non-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting agile practices. Through performing a literature review, this research has identified the perceived barriers to following agile practices when developing medical device software. A questionnaire based survey was also conducted with medical device software developers in Ireland to determine the barriers to adopting agile practices. The survey revealed that half of the respondents develop software in accordance with a plan driven software development lifecycle and that they believe that there are a number of perceived barriers to adopting agile practices when developing regulatory compliant software such as: being contradictory to regulatory requirements; insufficient coverage of risk management activities and the lack of up-front planning. In addition, a comparison is performed betw...
https://arrow.dit.ie/scschcomart/32
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Agile Medical Device Software Development: Introducing Agile Practices into MDevSPICE®
(2016)
McCaffery, Fergal; Lepmets, Marion; Trektere, Kitija; Ozcantop, Ozden; Pikkarainen, Minna
Agile Medical Device Software Development: Introducing Agile Practices into MDevSPICE®
(2016)
McCaffery, Fergal; Lepmets, Marion; Trektere, Kitija; Ozcantop, Ozden; Pikkarainen, Minna
Abstract:
Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. In order to develop a working medical device system through integrating its sub-systems, the sub-systems’ requirements have to be derived from the overall medical device system requirements. The system requirements are continuously collected, analysed and built from the needs of different stakeholders such as patients, health professionals and other companies offering relevant devices, interfaces and software related to the medical device system under development. Various regulatory requirements have to be achieved for a medical device to be allowed market access. We have developed and piloted a medical device software process assessment framework called MDevSPICE® that integrates the regulatory requirements from the relevant medical device software stan...
http://eprints.dkit.ie/593/
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Agile Usage in Embedded Software Development in Safety Critical Domain--A Systematic Review
(2018)
Demissie, Surafel; Keenan, Frank; Özcan-Top , Özden; McCaffery, Fergal
Agile Usage in Embedded Software Development in Safety Critical Domain--A Systematic Review
(2018)
Demissie, Surafel; Keenan, Frank; Özcan-Top , Özden; McCaffery, Fergal
Abstract:
Safety critical embedded software is a software that needs to provide correct functionality to avoid loss of human life. Embedded software controls much of the functionalities in Medical, Automotive, Aerospace and Cyber-Physical-Systems. The development of embedded software is different from ordinary software development as such development needs to be coordinated with the hardware development. Additionally, regulation processes and audits are also in place before placing the products to market. The objectives of this study are to understand the challenges of embedded safety critical software development, to investigate agile practices which have been in use in the domain, the factors affecting agile implementation in embedded safety critical software development. We have performed a systematic review to achieve these objectives. Our review has identified challenges related to hardware development, team-based communication and regulation process. This paper outlines the result of th...
http://eprints.dkit.ie/623/
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AHAA- Agile, Hybrid Assessment Method for Automotive, Safety Critical SMEs
(2008)
McCaffery, Fergal; Pikkarainen, Minna; Richardson, Ita
AHAA- Agile, Hybrid Assessment Method for Automotive, Safety Critical SMEs
(2008)
McCaffery, Fergal; Pikkarainen, Minna; Richardson, Ita
Abstract:
The need for software is increasingly growing in the automotive industry. Software development projects are, however, often troubled by time and budget overruns, resulting in systems that do not fulfill customer requirements. Both research and industry lack strategies to combine reducing the long software development lifecycles (as required by time-to-market demands) with increasing the quality of the software developed. Software process improvement (SPI) provides the first step in the move towards software quality, and assessments are a vital part of this process. Unfortunately, software process assessments are often expensive and time consuming. Additionally, they often provide companies with a long list of issues without providing realistic suggestions. The goal of this paper is to describe a new low-overhead assessment method that has been designed specifically for small-to-medium-sized (SMEs) organisations wishing to be automotive software suppliers. This assessment method int...
http://eprints.dkit.ie/120/
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